Enalapril Kern Pharma 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril Kern Pharma 20 mg tablets EFG

Enalapril maleate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Enalapril Kern Pharma is and what it is used for
2. What you need to know before taking Enalapril Kern Pharma
3. How to take Enalapril Kern Pharma
4. Possible side effects
5. How to store Enalapril Kern Pharma
6. Contents of the pack and other information

1. What Enalapril Kern Pharma is and what it is used for

Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). This medicine works by widening your blood vessels, thereby lowering your blood pressure. This allows your heart to pump blood around the body more easily.

Enalapril is indicated for:

• Treating hypertension (high blood pressure).
• Treating symptomatic heart failure (weakening of heart function).
• Preventing symptomatic heart failure.

2. What you need to know before taking Enalapril Kern Pharma

Do not take Enalapril Kern Pharma

• If you are allergic (hypersensitive) to enalapril or to any of the other components of this medicine (listed in section 6).
• If you have previously been treated with a medicine from the same drug class as enalapril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• If you have been diagnosed with hereditary or idiopathic angioedema (a condition causing large hives on the skin surface, especially around the eyes and lips, which may also affect hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. Enalapril should also be avoided in early pregnancy (see section Pregnancy).

Warnings and precautions

Consult your doctor or pharmacist before starting enalapril:

• If you have a heart condition (that obstructs blood flow out of the heart).
• If you have a disease affecting the blood vessels of the brain.
• If you have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis (a procedure to purify the blood when you have kidney problems).
• If you are receiving treatment with diuretics (medicines that increase urine elimination).
• If you have recently experienced excessive vomiting or diarrhea.
• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines associated with increased blood potassium levels (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus (high blood glucose levels) or any kidney problems (including kidney transplant), as these may lead to high blood potassium levels, which can be serious.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Please note that black patients are more susceptible to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis, or desensitization therapy to reduce the effects of an allergy to bee or wasp stings.
• If you have low blood pressure (you may experience dizziness or fainting, especially with initial doses and when standing up. In such cases, lying down may help).
• If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, or are taking allopurinol, procainamide, or any combination of these.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril Kern Pharma”.

You must inform your doctor if you think you are pregnant (or could be). Enalapril is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

Please note that enalapril is less effective in lowering blood pressure in black patients compared to non-black patients.

In all these cases, inform your doctor, as you may require a dose adjustment, discontinuation of enalapril, or monitoring of your blood potassium levels. If you have diabetes and are taking oral antidiabetic medicines or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with this medicine.

Before undergoing surgery or anesthesia (including at the dentist), inform your doctor or dentist that you are taking enalapril, as a sudden drop in blood pressure may occur in association with anesthesia.

Taking Enalapril Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to take any other medicines.

Certain medicines may interact with enalapril. Your doctor may need to adjust your dose and/or take other precautions, or discontinue treatment with one of the medicines.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril Kern Pharma” and “Warnings and precautions”).
• Other antihypertensive medicines (lower elevated blood pressure).
• Diuretics (medicines that increase urine elimination).
• Potassium-containing medicines (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medicines used in the treatment of psychosis).
• Anesthetics.
• Antidiabetics (medicines that lower blood glucose levels).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics (medicines that increase heart rate and blood pressure or dilate the bronchi).
• Certain medicines for pain or arthritis, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

Taking Enalapril Kern Pharma with food, drinks, and alcohol

Food does not affect the absorption of enalapril.

Alcohol enhances the hypotensive effect (lowering of blood pressure) of enalapril; therefore, it should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

Enalapril must not be used in pregnant women.

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended in newborns (first weeks after birth) while taking enalapril, especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments during breastfeeding.

Driving and using machines

Individual responses to medication may vary.

Since enalapril may cause dizziness or fatigue, avoid performing tasks that require special attention (such as driving or operating machinery) until you know how you tolerate the medicine.

Enalapril Kern Pharma contains lactose, sorbitol, and hydrogenated castor oil

This medicine contains lactose and sorbitol as excipients. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.

3. How to take Enalapril Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine how long you should take enalapril. Do not stop treatment prematurely.

Enalapril may be taken with meals or between meals, together with a glass of water.

The score line is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole.

Your doctor will decide the appropriate dose of enalapril for you, depending on your condition and whether you are taking other medications.

Hypertension

For most patients, the recommended initial dose is usually 5 to 20 mg once daily. Some patients may require a lower initial dose.

The usual long-term dose is 20 mg once daily.

The maximum long-term dose is 40 mg per day, divided into two doses.

Heart failure

The recommended initial dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your condition is reached. The usual long-term dose is 20 mg per day, given in one or two doses.

The maximum long-term dose is 40 mg per day, divided into two doses.

Extreme caution should be exercised at the beginning of treatment due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril Kern Pharma than you should

In case of overdose, the most likely symptom is dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Enalapril Kern Pharma

Continue taking enalapril as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril Kern Pharma

Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects have been coded according to the following frequency definitions: very common (at least 1 in 10 patients), common (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients), and very rare (less than 1 in 10,000 patients).

Blood and lymphatic system disorders:

Uncommon: anaemia (reduction in the number of red blood cells in the blood) (including aplastic and haemolytic anaemia).

Rare: blood disorders such as abnormally low neutrophil count (a type of blood cell), low haemoglobin levels, reduction or complete absence of granulocytes (a type of blood cell), deficiency of all types of blood cells, bone marrow suppression (tissue inside the bone that produces blood cells), lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon: low blood glucose levels.

Nervous and psychiatric disorders:

Common: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensation, dizziness.

Rare: sleep disturbances, sleep problems.

Eye disorders:

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: dizziness.

Common: drop in blood pressure (including drop in blood pressure upon standing), fainting, chest pain, irregular heartbeat, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease in blood pressure when sitting or standing), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain).

Rare: narrowing of arteries, usually in the fingers of the hands or feet, causing spasms that make the skin turn pale or mottled blue-red (Raynaud's phenomenon).

Respiratory disorders:

Very common: cough.

Common: difficulty breathing.

Uncommon: excessive watery nasal discharge, sore throat and hoarseness, asthma.

Rare: fluid in the lungs, inflammation of the nasal mucosal membrane, allergic inflammation of the lungs.

Gastrointestinal disorders:

Very common: nausea.

Common: diarrhoea, abdominal pain, altered taste.

Uncommon: intestinal obstruction, inflammation of the pancreas, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.

Rare: inflammation and ulcers in the mouth, inflammation of the tongue.

Hepatic disorders:

Rare: liver failure, inflammation of the liver (hepatitis), reduced or obstructed flow of bile from the bile duct to the liver (cholestasis including jaundice).

Skin and subcutaneous tissue disorders:

Common: skin rash, hypersensitivity or allergic reaction causing swelling of the face, limbs, lips, tongue, glottis and larynx.

Uncommon: sweating, pruritus (itching sensation), urticaria (red, itchy swellings), hair loss.

Rare: severe skin reaction, including excessive redness of the skin, blistering, skin peeling.

A set of symptoms has been observed which may include one or more of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components and usually detected in a blood test, skin rash, photosensitivity (hypersensitivity to sunlight), and other skin effects.

Renal and urinary disorders:

Uncommon: reduced kidney function or kidney failure, presence of protein in the urine.

Rare: reduction in the amount of urine produced per day.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: weakness.

Common: fatigue.

Uncommon: muscle cramps, flushing, tinnitus (ringing in the ears), malaise, fever.

Clinical laboratory tests:

Common: high potassium levels in blood, increased creatinine levels in blood.

Uncommon: increased blood urea levels, decreased sodium levels in blood.

Rare: increased liver enzymes, increased bilirubin levels in blood.

Stop taking enalapril and consult your doctor immediately if any of the following occur:

• swelling of the face, lips, tongue and/or throat causing difficulty breathing or swallowing,
• swelling of the hands, feet or ankles,
• appearance of urticaria (itching and redness in certain areas of the body).

Please note that black patients are more susceptible to these types of adverse reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril Kern Pharma

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Kern Pharma

• The active substance is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components (excipients) are: magnesium carbonate (E-540i), pregelatinized corn starch, monohydrate lactose, sorbitol (E-420), hydroxypropylcellulose (E-463), magnesium stearate, hydrogenated castor oil, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Enalapril Kern Pharma is presented as tablets.

Each pack contains 28 tablets. The tablets are orange-colored, cylindrical in shape, and scored on one side.

The score mark is intended to facilitate breaking the tablet and swallowing, but not to divide it into equal doses.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: February 2016

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)